BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    SET PP

    FDA 510(k)
    FDA Class 2 ·Dental

    SURGICAL TITANIUM MESH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CANDELA CLEARBEAM PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 8, 2023

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 25, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    SILCONE COATED I/A 45 HANDHELD INSTRUMENT

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

    VERCISE GEVIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 11, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 23, 2013

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 21, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024